Abstract

The fast and accurate detection of susceptibility in drugs is a major challenge for a successful tuberculosis (TB) control programme. This study evaluated the performance of WHO-endorsed rapid diagnostic tools, such as BACTEC MGIT 960 SIRE (MGIT SIRE), GenoType MTBDRplus (MTBDRplus) and Xpert MTB/RIF (Xpert), for detecting susceptibility to first-line anti-TB drugs among pulmonary TB patients in Bangladesh. A total of 825 sputum samples with results from drug susceptibility testing (DST) against first-line anti-TB drugs in the MGIT SIRE, MTBDRplus and Xpert assays were evaluated and compared with the gold standard proportion susceptibility method of the Lowenstein–Jensen (LJ) medium. The overall sensitivities of MGIT SIRE were 97.6%, 90.0%, 61.3% and 44.9%, while specificities were 89.9%, 94.5%, 91.3% and 92.2% for detection of susceptibility to isoniazid (INH), rifampicin (RIF), streptomycin (STR) and ethambutol (EMB), respectively. For MTBDRplus, the sensitivities were 88.0% and 88.7%, and the specificities were 97.4% and 97.8% for the detection of susceptibility to INH and RIF, respectively. Xpert demonstrated a sensitivity and specificity of 94.8% and 99.5%, respectively, for the detection of RIF susceptibility. All tests performed significantly better in retreated TB patients compared with primary TB cases. For detection of RIF and INH susceptibility, all three assays showed almost perfect agreement with the LJ method, although MGIT SIRE exhibited low agreement for STR and EMB. Considering the high performance, shorter turnaround time and ease of use, molecular-based approaches Xpert and MTBDRplus can be widely implemented throughout the country for the rapid detection of drug-resistant TB.

Highlights

  • Introduction published maps and institutional affilTuberculosis (TB) is an airborne infectious disease caused by Mycobacterium tuberculosis, and is the leading cause of death worldwide [1]

  • This study aims to evaluate the performance of World HealthOrganization (WHO)-approved rapid diagnostic tools, such as MGIT SIRE, MTBDRplus and Xpert, for detecting susceptibility to first-line anti-TB drugs among pulmonary TB

  • This study found that the MGIT SIRE had an overall good performance, with sensitivity and specificity of more than 90%, and almost perfect agreement (k = 0.83) with the LJ

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Summary

Introduction

Tuberculosis (TB) is an airborne infectious disease caused by Mycobacterium tuberculosis, and is the leading cause of death worldwide [1]. Organization (WHO), an estimated 9.9 million people globally developed TB in 2020, of whom about half a million had multidrug-resistant TB (MDR-TB). Bangladesh has a high incidence of TB with 360,000 cases, where an estimated 44,000 people die from the disease annually [1]. The first national survey on drug-resistant TB, which was conducted in 2011, revealed that the prevalence of MDR-TB in Bangladesh was 1.4% in new TB patients and. Failure to promptly diagnose and treat TB, DR-TB, results in increased transmission of the disease along with the development of resistance to additional anti-TB drugs [1,3].

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